To date, there are several widespread diseases that are often fatal and which generally involve a certain type of white blood cell that is responsible for orchestrating the immune system of the body. Among such diseases are adult T-Cell leukemia (ATL) and acquired immunodeficiency syndrome (AIDS). These diseases not only infect the same type of white blood cell, but further share another crucial feature in that they are all caused by a class of infectious agents known as retroviruses.
Retroviruses are viruses that cannot replicate without controlling and exploiting the biosynthetic apparatus of a cell for different purposes. Retroviruses consist of the genetic material of RNA and are capable of reversing the ordinary flow of genetic information (from DNA to RNA to proteins). Additionally, retroviruses carry an enzyme called reverse transcriptase which uses the viral RNA as a template for making DNA. The viral DNA integrates itself into the genome of the host wherein it remains latent until it is activated to make new virus particles. Much attention is being paid to the human immunodeficiency virus (HIV) retrovirus which causes AIDS due to its rapid transmission, progressive derangement of immune function, and high fatality rate.
It appears that the HIV retrovirus enters a cell by binding to a molecule known as the CD4 antigen. The CD4 antigen is found primarily on a specific set of white blood cells of the immune system called T4 lymphocytes or helper T-cells. Accordingly, HIV infection is characterized by the loss of these T-lymphocyte cells which causes a deterioration of the immune system.
The T-lymphocyte cell is crucial to the immune system in that, among other functions, it recognizes foreign antigens, markers, or infected cells, and helps to activate another set of lymphocyte white blood cells which multiply and produce antibodies that bind to infected cells. The T-lymphocyte cell further is capable of completely eliminating infected cells. Thus, the loss of T-lymphocyte cells not only seriously impairs the body's ability to fight most invaders, but also has a severe impact on the defenses against viruses, fungi, parasites, and certain bacteria.
In the case of AIDS and some forms of hepatitis and leukemia, it is the secondary infections which are the actual cause of death. My previous patent, U.S. Pat. No. 5,091,181 was directed to the need for treating such immune deficiency-causing diseases by means that would boost the suppressed lymphocyte levels and provide a defense against life-threatening secondary infections.
Presently, there is no known cure for AIDS. There are, however, various experimental drugs on the market, including an antiviral substance known as azidothymidine (AZT) which has been shown to prolong the lives of certain AIDS subjects. These drugs are, for the most part, extremely expensive and often difficult to obtain.
Thus, although there is no cure for AIDS, early intervention with antiretroviral therapy can substantially decrease the risk of opportunistic infections and may improve the survival of subjects with HIV infection. Accordingly, a procedure to detect the virus itself rather than the immune response to the virus is critical.
There are several known diagnostic techniques for detecting HIV infection in adults and children. One such diagnostic technique is the immune-complex-dissociated HIV p24 antigen assay which is a rapid, simple serologic test that may be used to diagnose HIV infection. The p24 antigen of human immunodeficiency virus type 1 (HIV-1) is sometimes detected before antibody (anti-HIV-1) is detectable in the serum of recently infected persons. This is because the p24 antigen is usually present in the circulation of the HIV-infected subject shortly after infection with HIV-1 and before the development of a humoral response. Thus, the HIV p24 antigen assay reveals the presence of circulating p24 antigen which appears to stimulate the often rapid development of the AIDS virus.
Accordingly, it is an object of the present invention to provide a method for treating HIV positive subjects to combat the virus.
A further object of the present invention is to provide a method for treating HIV positive subjects that is easily administered to the subject and which is relatively inexpensive.
Yet another object of the present invention is to provide a method for treating HIV positive subjects.
The objectives and advantages of the present invention are achieved by providing a method for treating HIV positive subjects by administering an effective amount of a therapeutically active composition to a subject. The composition used in the method has a medicinal application and has resulted in a negative reading for the p24 (HIV) antigen in a subject that initially tested positive for the p24 (HIV) antigen. Also, the composition used in the method maintained a negative reading for the p24 (HIV) antigen in a subject that initially tested negative for the p24 (HIV) antigen.
The foregoing composition used in the inventive method includes as an active pharmaceutical an extract of at least one edible plant or herb. Specifically, the herb is a Mediterranean and West Asiatic plant known as Asphodelus tenuifolius. The genus Asphodelus describes a hardy, herbaceous stemless plant having white, lily-like flowers in long racemes, fleshy fascicled roots and firm, linear, radical,.tufted leaves. It generally grows as a common weed in the above-cited locations.
More specifically, the composition derives from one species of asphodel, a purple-flowering variant of Asphodelus tenuifolius which occurs in Greece and Turkey. This identification is based on R. M. T. Dahlgren, et al's "The Families of Monocotyledons--Structure, Evolution and Taxonomy", Springer-Verlag, New York (1985).
Minor discrepancies of plant classification are often found between different botanists' works. Therefore, A. tenuifolius has been described as "identical" to A. microcarpus and A. aestivus by some classifiers of the plant (see Bailey, Standard Cyclopedia of Horticulture, Macmillan Co., New York, 1935), and alternatively as "allied to" A. Fistulosis by others (see Chittenden, Dictionary of Gardening, Clarendon Press Oxford, 1956). These species are closely related. Accordingly, it is expected that asphodel species other than A. tenuifolius will be identified which will yield an equally therapeutic composition.
My U.S. Pat. No. 5,091,181 is directed to providing a composition for increasing the white cell levels in subjects by use of an herbal composition. The composition used in that patent is the same as is used in this invention. However, I have also provided the additional composition of using a mixture of the herbal extract of U.S. Pat. No. 5,091,181 with a cortisone.
Thus, the inventive method herein involves treating HIV positive subjects with an extract derived from an edible plant known as Asphodelus tenuifolius or its chemical equivalent. The plant is collected in its dry form. A certain methodology has been developed for the extraction process (see U.S. Pat. No. 5,091,181). This methodology involves using the entire plant in the production of the extract, including the whole woody stem, the root system, the loculicidal capsules, and the seeds. The extract dosage for each subject is approximately 150 mls per dose. The extract is administered orally, twice a day with a 10-12 hour interval in between the doses. The average treatment for high risk cases lasts 30-45 days (i.e., full blown AIDS), and for simple cases the treatment lasts for 10-20 days (i.e., HIV positive). All subjects who underwent treatment were under the supervision of their private doctors. Moreover, it was recommended that the subjects undergo daily non-strenuous, light exercises along with a specific low fat diet program.
Prior to the Examples as hereinafter set forth wherein various subjects ingested the extract, the toxicity of the plant extract used in the inventive method was tested in two independent toxicity studies. Each study was directed to examining the behavioral and physiological aspects of laboratory animals which were given the plant extract.
The first study involved using five rabbits as models. Animal rooms and cages were cleansed and sanitized prior to initiating the study and then weekly thereafter. The light/dark cycle in the animal rooms and cages was kept on a 12L:12D schedule while the temperature was maintained at 70-75 degrees Fahrenheit. The normal water supply of the test animals was replaced with the plant extract for a two week period. Thereafter, city quality tap water was again supplied. No irregularities in the animals' behavior subsequent to plant extract consumption were noted. Thus, the non-toxicity of the extract was confirmed. Moreover, two days after returning the animals back to the tap water, a limited gross necropsy was performed on two of the animals to examine any change in the internal organs. No apparent changes were observed in these animals. The rest of the animals were examined again after a two month period and there were still no discernible effects on the animals. The first study lasted approximately two months.
A second toxicity study was carried out with a group of ten mice. This study involved varying the concentration of the extract. The variable concentrations were calculated by ratios between parts of the plant weight in grams and solvent volume. Thus, the mice were administered 1 ml doses of plant extract at concentrations of 25%, 50%, and 100%. Again, no adverse reactions were noted. The test animals appeared normal irrespective of dose, supporting a second conclusion of non-toxicity. All animals were kept in accordance with accepted animal care practice.